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Carglumic acid 200 mg Tablet, For Suspension, 60-count — NDC 68475-0006-02 package photo
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Carglumic acid 200 mg Tablet, For Suspension, 60-count — NDC 68475-006-02 (Billing 68475-0006-02)

by Navinta LLC · 60 TABLET, FOR SUSPENSION in 1 BOTTLE

This is a package of 60 tablets of Carglumic acid 200 mg Tablet, For Suspension from Navinta LLC, marketed since Aug 2022 and currently FDA-listed.

NDC 68475-0006-02
🏷️ FDA NDC (as labeled) 68475-006-02 billing pads the product segment with a zero
This package
Contains60-count Pack sizes2 compare ↓
Also priced by: Part D plans $163.29/unit — full pricing hub ↓
Product page 68475-0006-01 Also comes in: 5 tablets 68475-006-01
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 68475-006-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68475 labeler · 006 product · 02 package
Package marketed since
Aug 1, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6847500602 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68475-006-02
Product NDC 68475-006
11-digit billing NDC 68475000602
RxCUI 905390
UNII 5L0HB4V1EW
Application # ANDA213395
SPL Set ID 59e73eb8-edf8-4fad-93c2-deb6b23497f8
Established class (EPC) Carbamoyl Phosphate Synthetase 1 Activator
Mechanism of action Carbamoyl Phosphate Synthetase 1 Activators
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-08-01
Route ORAL
Dosage form TABLET, FOR SUSPENSION
Substance CARGLUMIC ACID
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 905390
Why two NDCs? The FDA registers this code as 68475-006-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68475-0006-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Carbamoyl Phosphate Synthetase 1 Activator class.

Pharmacologic class Carbamoyl Phosphate Synthetase 1 Activator
Drug family (ATC) Amino acids and derivatives
How it works Carbamoyl Phosphate Synthetase 1 Activators
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $163.29 —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68475-0006-01 68475-006-01 Main listing 5 TABLET, FOR SUSPENSION in 1 BOTTLE 2022-08-01 — Active
68475-0006-02 You're viewing this 60 TABLET, FOR SUSPENSION in 1 BOTTLE 2022-08-01 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 tablet, for suspension in 1 bottle.
How does this package differ from NDC 68475-0006-01?
Both are Carglumic acid 200 mg Tablet, For Suspension — the drug itself is identical. This page's package is the 60-count one, while NDC 68475-0006-01 is the 5 tablets package.
What NDC number is used to bill for this package of Carglumic acid 200 mg Tablet, For Suspension?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Carglumic acid 200 mg 35573-0459-60 Burel 60 tablets — AB FDA listed —
Carbaglu 200 mg 52276-0312-05 Recordati 5 tablets — AB FDA listed —
Carglumic acid 200 mgthis 68475-0006-02 Navinta 60 tablets — AB FDA listed —
Carglumic Acid 200 mg 71863-0114-60 Eton 60 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Aug 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
ShapeRectangle
Size18 mm
ScoringScore: 3
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 25 mg UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 167.7 mg UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 100.3 mg UNII KO5GYV0DCB
    Microcrystalline cellulose is a purified plant fiber used as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and improves how the medicine breaks apart in your body.
  • 1.5 mg UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 0.5 mg UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 5 mg UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerNavinta LLC
Application holderNAVINTA LLC
FDA applicationANDA213395 (ANDA)
Labeler code68475
First marketedAug 2022
Product typeHuman Prescription Drug
Portfolio20 products on file

More NDCs from Navinta LLC labeler code 68475

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 117 words ▾

1 INDICATIONS AND USAGE Carglumic acid tablets for oral suspension is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated in pediatric and adult patients as: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. ( 1.1 ) Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency. ( 1.1 )

1.1Acute and Chronic Hyperammonemia due to N-acetylglutamate Synthase (NAGS) Deficiency Carglumic acid tablets for oral suspension is indicated in adult and pediatric patients as: • Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to NAGS deficiency. • Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Acute Hyperammonemia due to NAGS deficiency ( 2.2 ) The recommended dosage in adult and pediatric patients is 100 mg/kg to 250 mg/kg orally daily. Divide the daily dosage into 2 to 4 doses. Chronic Hyperammonemia due to NAGS deficiency (2.2) The recommended dosage in adult and pediatric patients is 10 mg/kg to 100 mg/kg orally daily.

Divide the daily dosage into 2 to 4 doses. Therapeutic Monitoring for NAGS Deficiency (2.2) Closely monitor plasma ammonia and titrate dosage to maintain the ammonia level within normal range for the patient's age, taking into consideration their clinical condition. Patients with Renal Impairment ( 2.4 ) See Full Prescribing Information for Instructions on Dosage Adjustment.

Preparation and Administration ( 2.5 ) Disperse carglumic acid tablets for oral suspension in water. Do not swallow whole or crushed. Take immediately before meals or feedings.

For additional instructions on preparation and administration orally or through a nasogastric tube or gastrostomy tube, see the full prescribing information.

2.1Important Administration Instructions Disperse carglumic acid tablets for oral suspension in water. Do not swallow whole or crush [see Dosage and Administration ( 2.5 )] . Carglumic acid tablets for oral suspension may be administered by mouth or via a nasogastric or gastrostomy tube [see Dosage and Administration ( 2.5 )].

2.2Recommended Dosage for Acute or Chronic Hyperammonemia due to NAGS Deficiency Treatment Initiation Initiate Carglumic acid tablets for oral suspension treatment as soon as the diagnosis of NAGS deficiency is suspected, which may be as soon as at birth, and supervised by a healthcare provider experienced in the treatment of metabolic disorders. Dosage for Acute Hyperammonemia due to NAGS Deficiency • The recommended dosage of Carglumic acid tablets for oral suspension in adult and pediatric patients for acute hyperammonemia due to NAGS deficiency is (based on actual body weight) 100 mg/kg to 250 mg/kg orally daily. • Divide the daily dosage into 2 to 4 doses and round to the nearest 100 mg (i.e., half of a Carglumic acid tablets for oral suspension). • During acute hyperammonemic episodes, administer Carglumic acid tablets for oral suspension with other ammonia lowering therapies, such as alternate pathway medications, hemodialysis, and protein restriction.

Dosage for Chronic Hyperammonemia due to NAGS Deficiency • The recommended daily dosage of Carglumic acid tablets for oral suspension in adult and pediatric patients for chronic hyperammonemia due to NAGS deficiency is (based on actual body weight) 10 mg/kg to 100 mg/kg orally daily. • Divide the daily dosage into 2 to 4 doses and round to the nearest 100 mg (i.e., half of a Carglumic acid tablets for oral suspension). • During maintenance therapy, the concomitant use of other ammonia lowering therapies and protein restriction may be needed based on plasma ammonia levels.

Therapeutic Monitoring Closely monitor plasma ammonia levels. Titrate the Carglumic acid tablets for oral suspension dosage to maintain the plasma ammonia level within the normal range for the patient's age, taking into consideration their clinical condition (e.g., nutritional requirements, protein intake, growth parameters, etc.). Adjust the recommended dosage in patients with moderate or severe renal impairment [see Dosage and Administration ( 2.4 )] .

2.4Dosage Adjustment in Patients with Renal Impairment No dosage adjustment is warranted in patients with mild renal impairment (eGFR 60-89 mL/min/1.73 m 2 ). The recommended dosage of carglumic acid tablets for oral suspension in patients with moderate or severe renal impairment is shown below. Moderate Renal Impairment (eGFR 30-59 mL/min/1.73 m 2 ) Severe Renal Impairment (eGFR 15-19 mL/min/1.73 m 2 ) Acute Hyperammonemia due to NAGS Deficiency 50 mg/kg/day to 125 mg/kg/day divided into 2 to 4 doses and rounded to the nearest 50 mg (i.e., one-quarter of a carglumic acid… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 45 words ▾

3 DOSAGE FORMS AND STRENGTHS Carglumic acid tablets for oral suspension 200 mg are white to off-white elongated tablets, functionally scored with 3 lines (for splitting into 4 equal portions) and engraved "N" on one side. Tablets for oral suspension: 200 mg, functionally scored (3)

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None None.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS NAGS deficiency : Most common adverse reactions (≥13%) are vomiting, abdominal pain, pyrexia, tonsillitis, anemia, diarrhea, ear infection, infections, nasopharyngitis, hemoglobin decreased, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Navinta LLC at 1-609-883-1135, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Acute and Chronic Hyperammonemia due to NAGS Deficiency In a retrospective case series of 23 NAGS deficiency patients treated with Carglumic acid tablets for oral suspension, 17 of the 23 patients reported an adverse reaction.

The most common adverse reactions (occurring in ≥ 13% of patients) were vomiting, abdominal pain, pyrexia, tonsillitis, anemia, diarrhea, ear infection, infections, nasopharyngitis, hemoglobin decreased, and headache. Table 1 summarizes adverse reactions occurring in 2 or more patients treated with carglumic acid tablets for oral suspension. Table 1: Adverse Reactions Reported in ≥ 2 Patients with NAGS deficiency Treated with Carglumic Acid Tablets for Oral Suspension in the Retrospective Case Series Adverse Reaction Number of Patients (N) (%) Vomiting 6 (26) Abdominal pain 4 (17) Pyrexia 4 (17) Tonsillitis 4 (17) Anemia 3 (13) Diarrhea 3 (13) Ear infection 3 (13) Infections 3 (13) Nasopharyngitis 3 (13) Hemoglobin decreased 3 (13) Headache 3 (13) Dysgeusia 2 (9) Asthenia 2 (9) Hyperhidrosis 2 (9) Influenza 2 (9) Pneumonia 2 (9) Weight decreased 2 (9) Anorexia 2 (9) Somnolence 2 (9) Rash 2 (9)

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of Carglumic acid tablets for oral suspension. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. Psychiatric disorders : mania Skin and subcutaneous tissue disorders : pruritus, rash including rash erythematous, rash maculopapular, rash pustular

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Although rare case reports of carglumic acid tablets for oral suspension use in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, untreated NAGS deficiency can result in irreversible neurologic damage and death in pregnant women (see Clinical Considerations ). In an animal reproduction study, decreased survival and growth occurred in offspring born to rats that received carglumic acid at a dose approximately 38 times the maximum reported human maintenance dose.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, miscarriage, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnant women with urea cycle disorders may experience an increase in catabolic stress which can trigger a hyperammonemic crisis both in the intrapartum and in the post-partum (3 - 14 days post-partum) periods. Maternal complications related to hyperammonemic crisis can include neurological impairment, coma and in some cases death. Data Animal Data No effects on embryo-fetal development were observed in pregnant rats treated with up to 2000 mg/kg/day (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC [area under the plasma concentration-time curve]) from two weeks prior to mating through organogenesis or in pregnant rabbits treated with up to 1000 mg/kg/day (approximately 6 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC) during organogenesis.

In a pre- and post-natal developmental study, female rats received oral carglumic acid from organogenesis through lactation at doses of 500 mg/kg/day and 2000 mg/kg/day. Decreased growth of offspring was observed at 500 mg/kg/day and higher (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC), and reduction in offspring survival during lactation was observed at 2000 mg/kg/day (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC).

No effects on physical and sexual development, learning and memory, or reproductive performance were observed through maturation of the surviving offspring at maternal doses up to 2000 mg/kg/day. The high dose (2000 mg/kg/day) produced maternal toxicity (impaired weight gain and approximately 10% mortality).

8.2Lactation Risk Summary It is not known whether carglumic acid is present in human milk. There are no available data on the effects of carglumic acid on the breastfed infant or the effects on milk production. Carglumic acid is present in milk from treated rats.

When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for carglumic acid tablets for oral suspension and any potential adverse effects on the breastfed child from carglumic acid tablets for oral suspension or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of carglumic acid tablets for oral suspension for the treatment of pediatric patients (birth to 17 years of age) with acute or chronic hyperammonemia due to NAGS deficiency have been established, and the information on these uses are discussed throughout the labeling. There are insufficient data to determine if there is a difference in clinical or biochemical responses between adult and pediatric patients treated with Carglumic acid tablets for oral suspension.

8.5Geriatric Use Clinical studies of Carglumic acid tablets for oral susp… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Although rare case reports of carglumic acid tablets for oral suspension use in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, untreated NAGS deficiency can result in irreversible neurologic damage and death in pregnant women (see Clinical Considerations ). In an animal reproduction study, decreased survival and growth occurred in offspring born to rats that received carglumic acid at a dose approximately 38 times the maximum reported human maintenance dose.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, miscarriage, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnant women with urea cycle disorders may experience an increase in catabolic stress which can trigger a hyperammonemic crisis both in the intrapartum and in the post-partum (3 - 14 days post-partum) periods. Maternal complications related to hyperammonemic crisis can include neurological impairment, coma and in some cases death. Data Animal Data No effects on embryo-fetal development were observed in pregnant rats treated with up to 2000 mg/kg/day (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC [area under the plasma concentration-time curve]) from two weeks prior to mating through organogenesis or in pregnant rabbits treated with up to 1000 mg/kg/day (approximately 6 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC) during organogenesis.

In a pre- and post-natal developmental study, female rats received oral carglumic acid from organogenesis through lactation at doses of 500 mg/kg/day and 2000 mg/kg/day. Decreased growth of offspring was observed at 500 mg/kg/day and higher (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC), and reduction in offspring survival during lactation was observed at 2000 mg/kg/day (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC).

No effects on physical and sexual development, learning and memory, or reproductive performance were observed through maturation of the surviving offspring at maternal doses up to 2000 mg/kg/day. The high dose (2000 mg/kg/day) produced maternal toxicity (impaired weight gain and approximately 10% mortality).

🧒 Pediatric Use 78 words ▾

8.4Pediatric Use The safety and effectiveness of carglumic acid tablets for oral suspension for the treatment of pediatric patients (birth to 17 years of age) with acute or chronic hyperammonemia due to NAGS deficiency have been established, and the information on these uses are discussed throughout the labeling. There are insufficient data to determine if there is a difference in clinical or biochemical responses between adult and pediatric patients treated with Carglumic acid tablets for oral suspension.

🧓 Geriatric Use 31 words ▾

8.5Geriatric Use Clinical studies of Carglumic acid tablets for oral suspension did not include patients 65 years of age and older to determine whether they respond differently from younger patients.

🆘 Overdosage 44 words ▾

10 OVERDOSAGE One patient treated with 650 mg/kg/day of Carglumic acid tablets for oral suspension developed symptoms resembling monosodium glutamate intoxication-like syndrome and characterized by tachycardia, profuse sweating, increased bronchial secretion, increased body temperature, and restlessness. These symptoms resolved upon reduction of the dose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Carglumic acid is a synthetic structural analogue of N-acetylglutamate (NAG) which is produced from glutamate and acetyl-CoA in a reaction catalyzed by N-acetylglutamate synthase (NAGS), a mitochondrial liver enzyme. NAG acts as an essential allosteric activator of carbamoyl phosphate synthetase 1 (CPS 1), a mitochondrial liver enzyme which catalyzes the first reaction of the urea cycle. The urea cycle, whose role is the disposition of ammonia, includes a series of biochemical reactions in the liver resulting in the conversion of ammonia into urea, which is then excreted through the urine.

Carglumic acid acts as a CPS1 activator, improves or restores the function of the urea cycle, and facilitates ammonia detoxification and urea production.

12.2Pharmacodynamics In a retrospective review of the clinical course in 23 patients with NAGS deficiency, carglumic acid reduced plasma ammonia levels within 24 hours when administered with and without concomitant ammonia lowering therapies. No dose-response relationship has been identified. Cardiac Electrophysiology The effect of carglumic acid was evaluated in a Phase 1, randomized study in 76 healthy volunteers.

The study suggests a lack of clinically relevant QT prolongation effect at the highest therapeutic dose level (250 mg/kg/day).

12.3Pharmacokinetics The pharmacokinetics of carglumic acid in healthy subjects following an intravenous (IV) infusion over 2 hours at 8 mg/kg or an oral administration at 100 mg/kg are summarized in Table 3 . Table 3: Mean (SD) Pharmacokinetic Parameter Values of Carglumic Acid in Healthy Subjects # Median (range); N/A, not applicable. PK parameter IV infusion 8 mg/kg (N=10) Oral 100 mg/kg (N=12) C max (ng/mL) 8613 (558) 3284 (321) T max (hr) # 2 (1-2) 3 (2-4) AUC (ng*hr/mL) 24501 (1613) 31426 (2150) T 1/2 (hr) 31 (3) 25 (2) CL (L/hr/kg) 0.34 (0.02) N/A Vd (L/kg) 15 (1) N/A Absorption Following an oral administration of Carglumic acid tablets for oral suspension 100 mg/kg in healthy subjects, the absolute bioavailability was approximately 10%.

Distribution Carglumic acid is not bound to plasma proteins. Elimination Carglumic acid is predominantly excreted by the kidneys as unchanged product. Metabolism A proportion of carglumic acid may be metabolized by the intestinal bacterial flora.

The likely end product of carglumic acid metabolism is carbon dioxide, eliminated through the lungs. Excretion Following an oral administration of radiolabeled carglumic acid tablets for oral suspension at 100 mg/kg, 9% of the dose is excreted unchanged in the urine and up to 60% of the dose is recovered unchanged in the feces. Specific Populations Patients with Renal Impairment The pharmacokinetics of carglumic acid in subjects with renal impairment were compared with healthy subjects with normal renal function following oral administration of a single dose of carglumic acid tablets for oral suspension 40 mg/kg or 80 mg/kg.

The C max and AUC 0-t of carglumic acid are summarized in Table 4 . The geometric mean ratio (90% CI) of C max in subjects with mild, moderate, and severe renal impairment relative to those in their matched control subjects with normal renal function were approximately 1.3 (0.95, 1.86), 2.0 (1.62, 2.50), and 4.4 (3.11, 6.28) respectively. The geometric mean ratio (90% CI) of AUC 0-t in subjects with mild, moderate, and severe renal impairment relative to those in their matched control subjects with normal renal function were approximately 1.4 (1.09, 1.73), 2.8 (2.27, 3.47), and 6.9 (5.21, 9.24), respectively [see Dosage and Administration ( 2.4 )] .

Table 4: Mean (SD) C max and AUC 0- t of Carglumic Acid Following Single Oral Dose Administration of carglumic acid tablets for oral suspension 80 mg/kg or 40 mg/kg in Subjects with Renal Impairment and Matched Healthy Control Subjects with Normal Renal Function Treatment groups 1a and 1b represent two separate matched control groups of healthy subjects w… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 117 words ▾

12.1Mechanism of Action Carglumic acid is a synthetic structural analogue of N-acetylglutamate (NAG) which is produced from glutamate and acetyl-CoA in a reaction catalyzed by N-acetylglutamate synthase (NAGS), a mitochondrial liver enzyme. NAG acts as an essential allosteric activator of carbamoyl phosphate synthetase 1 (CPS 1), a mitochondrial liver enzyme which catalyzes the first reaction of the urea cycle. The urea cycle, whose role is the disposition of ammonia, includes a series of biochemical reactions in the liver resulting in the conversion of ammonia into urea, which is then excreted through the urine.

Carglumic acid acts as a CPS1 activator, improves or restores the function of the urea cycle, and facilitates ammonia detoxification and urea production.

📦 How Supplied / Storage and Handling 168 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Carglumic acid tablets for oral suspension 200 mg are white to off-white elongated tablets, functionally scored with 3 lines for splitting into 4 equal portions, and engraved 'N's on one side. Carglumic acid tablets for oral suspension is supplied in a high-density polyethylene bottle with a child resistant polypropylene cap and desiccant unit. Each bottle contains either 5 or 60 tablets.

Bottle of 5 tablets: NDC 68475-006-01 Bottle of 60 tablets: NDC 68475-006-02 Storage Store at 20° to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. After first opening of the bottle: Store at room temperature between 15°C and 30°C (59°F and 86°F). Do not refrigerate.

Keep the bottle tightly closed between openings in order to protect from moisture. Write the date of opening on the bottle. Do not use carglumic acid tablets for oral suspension after the expiration date stated on the bottle.

Discard bottle one month after first opening.

📋 Description 100 words ▾

11 DESCRIPTION Carglumic acid tablets for oral suspension contain 200 mg of carglumic acid. Carglumic acid, the active substance, is a carbamoyl phosphate synthetase 1 (CPS 1) activator and is soluble in dimethyl formamide and sparingly soluble in water. The chemical name of carglumic acid is N-carbamoyl-L-glutamic acid or (2S)-2-(carbamoylamino) pentanedioic acid.

The empirical formula is C 6 H 10 N 2 O 5 and the molecular weight is 190.16. The structural formula is: The inactive ingredients of carglumic acid tablets for oral suspension are croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulfate, colloidal silicon dioxide and sodium stearyl fumarate. Image

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Advise the patient or caregiver on the following: Preparation and Administration [see Dosage and Administration (2.5) ] Disperse carglumic acid tablets for oral suspension in water. Do not swallow whole or crushed.

Take carglumic acid tablets for oral suspension immediately before meals or feedings. Carglumic acid tablets for oral suspension dispersed in water can be administered orally or via a nasogastric tube or gastrostomy tube, as described in the Instructions for Use . Storage [see How Supplied/Storage and Handling ( 16 )] Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] After first opening of the bottle: Do not refrigerate.

Store at room temperature between 15° to 30°C (59° to 86°F). Keep the bottle tightly closed in order to protect from moisture. Write the date of opening on the bottle.

Discard bottle one month after first opening. Do not use carglumic acid tablets for oral suspension after the expiration date stated on the bottle. Manufactured for: Navinta LLC 1499 lower Ferry Road, Ewing, NJ 08618 Revised: 03/2024 31230622 R1 INSTRUCTIONS FOR USE Carglumic Acid Tablets for Oral Suspension Important information: Carglumic acid tablet for oral suspension must be mixed in water before taking.

Carglumic acid tablets for oral suspension should not be mixed in any other food or liquid. Do not swallow carglumic acid tablets for oral suspension whole. Do not crush carglumic acid tablets for oral suspension.

Take carglumic acid tablets for oral suspension right before meals or feedings. The carglumic acid tablet for oral suspension and water mixture has a slightly sour taste. You may need to ask your healthcare provider or pharmacist for a medicine cup to measure the correct amount of water you will need to prepare the dose of carglumic acid tablets for oral suspension.

The Carglumic acid tablets for oral suspension has 3 lines used for splitting the tablet into 4 equal parts in order to get the prescribed dose. Ask your healthcare provider if you have any questions about how to split the tablet the right way or have any questions about the prescribed dose. Taking carglumic acid tablets for oral suspension by mouth using a cup: Children and Adults Add a minimum 2.5 mL of water into a small cup for each carglumic acid tablet for oral suspension, or each ½ or ¼ carglumic acid tablet for oral suspension, needed for the prescribed dose.

For example: If the prescribed dose is 2 carglumic acid tablets for oral suspension, add a minimum of 5 mL of water into the cup. If the prescribed dose is 2 and a ¼ carglumic acid tablets for oral suspension, add a minimum of 7.5 mL of water into the cup. If the prescribed dose is 2 and a ½ carglumic acid tablets for oral suspension, add a minimum of 7.5 mL of water into the cup.

Ask your healthcare provider if you are not sure of how much water you should use for the prescribed dose of carglumic acid tablets for oral suspension Place the prescribed number of carglumic acid tablets for oral suspension into the water in the cup. Carefully stir the carglumic acid tablet for oral suspension and water mixture in the cup to avoid spilling the mixture. Carglumic acid tablets for oral suspension do not dissolve completely in water.

Swallow the carglumic acid tablet for oral suspension and water mixture right away . Pieces of the tablet may remain in the cup. Add more water to the cup to rinse the cup and swallow the mixture right away .

Repeat step 5 until there are no pieces of the tablet left in the cup. Taking carglumic acid tablets for oral suspension by mouth using an oral syringe: Children Add a minimum of 2.5 mL of water into a small cup for each carglumic acid tablet for oral suspension, or each ½ or ¼ carglumic acid tablet for oral suspension, needed for the prescribed dose. For Example: If the prescrib… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics of carglumic acid in healthy subjects following an intravenous (IV) infusion over 2 hours at 8 mg/kg or an oral administration at 100 mg/kg are summarized in Table 3 . Table 3: Mean (SD) Pharmacokinetic Parameter Values of Carglumic Acid in Healthy Subjects # Median (range); N/A, not applicable. PK parameter IV infusion 8 mg/kg (N=10) Oral 100 mg/kg (N=12) C max (ng/mL) 8613 (558) 3284 (321) T max (hr) # 2 (1-2) 3 (2-4) AUC (ng*hr/mL) 24501 (1613) 31426 (2150) T 1/2 (hr) 31 (3) 25 (2) CL (L/hr/kg) 0.34 (0.02) N/A Vd (L/kg) 15 (1) N/A Absorption Following an oral administration of Carglumic acid tablets for oral suspension 100 mg/kg in healthy subjects, the absolute bioavailability was approximately 10%.

Distribution Carglumic acid is not bound to plasma proteins. Elimination Carglumic acid is predominantly excreted by the kidneys as unchanged product. Metabolism A proportion of carglumic acid may be metabolized by the intestinal bacterial flora.

The likely end product of carglumic acid metabolism is carbon dioxide, eliminated through the lungs. Excretion Following an oral administration of radiolabeled carglumic acid tablets for oral suspension at 100 mg/kg, 9% of the dose is excreted unchanged in the urine and up to 60% of the dose is recovered unchanged in the feces. Specific Populations Patients with Renal Impairment The pharmacokinetics of carglumic acid in subjects with renal impairment were compared with healthy subjects with normal renal function following oral administration of a single dose of carglumic acid tablets for oral suspension 40 mg/kg or 80 mg/kg.

The C max and AUC 0-t of carglumic acid are summarized in Table 4 . The geometric mean ratio (90% CI) of C max in subjects with mild, moderate, and severe renal impairment relative to those in their matched control subjects with normal renal function were approximately 1.3 (0.95, 1.86), 2.0 (1.62, 2.50), and 4.4 (3.11, 6.28) respectively. The geometric mean ratio (90% CI) of AUC 0-t in subjects with mild, moderate, and severe renal impairment relative to those in their matched control subjects with normal renal function were approximately 1.4 (1.09, 1.73), 2.8 (2.27, 3.47), and 6.9 (5.21, 9.24), respectively [see Dosage and Administration ( 2.4 )] .

Table 4: Mean (SD) C max and AUC 0- t of Carglumic Acid Following Single Oral Dose Administration of carglumic acid tablets for oral suspension 80 mg/kg or 40 mg/kg in Subjects with Renal Impairment and Matched Healthy Control Subjects with Normal Renal Function Treatment groups 1a and 1b represent two separate matched control groups of healthy subjects with normal renal function. PK Parameters Normal Renal Function 1a : eGFR ≥90 mL/min/1.73m 2 (N=8) Mild Renal Impairment: eGFR 60-89 mL/min/1.73m 2 (N=8) Moderate Renal Impairment: eGFR 30-59 mL/min/1.73m 2 (N=8) Normal Renal Function 1b : eGFR ≥90 mL/min/1.73m 2 (N=8) Severe Renal Impairment: eGFR 15-29 mL/min/1.73m 2 (N=8) 80 mg/kg 40 mg/kg C max (ng/mL) 2983 (552) 4310 (1937) 6129 (1854) 1890 (901) 8377 (3815) AUC 0-t (ng*hr/mL) 28313 (6204) 39545 (12109) 79766 (19708) 20212 (6186) 143075 (55910) Drug Interaction Studies Based on in vitro studies, carglumic acid is not an inducer of CYP1A1/2, CYP2B6, CYP2C, and CYP3A4/5 enzymes, and not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4/5 enzymes.

Based on in vitro studies, carglumic acid is a substrate of the human OAT1 transporter. Carglumic acid is not a substrate of MDR1, BCRP, MATE1, MATE2-K, OAT1, OAT3, OATP1B1, OATP1B3, OCT1, and OCT2. Carglumic acid is not an inhibitor of human BSEP, BCRP, MDR1, MATE1, MATE2-K, OAT1, OAT3, OATP1B1, OATP1B3, OCT1, and OCT2 transporters.

🧬 Pharmacodynamics 78 words ▾

12.2Pharmacodynamics In a retrospective review of the clinical course in 23 patients with NAGS deficiency, carglumic acid reduced plasma ammonia levels within 24 hours when administered with and without concomitant ammonia lowering therapies. No dose-response relationship has been identified. Cardiac Electrophysiology The effect of carglumic acid was evaluated in a Phase 1, randomized study in 76 healthy volunteers.

The study suggests a lack of clinically relevant QT prolongation effect at the highest therapeutic dose level (250 mg/kg/day).

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Acute and Chronic Hyperammonemia due to NAGS Deficiency The efficacy of carglumic acid tablets for oral suspension in the treatment of acute and chronic hyperammonemia due to NAGS deficiency was evaluated in a retrospective case series of 23 NAGS deficiency patients treated with Carglumic acid tablets for oral suspension over a median duration of 7.9 years (range 0.6 to 20.8 years). For acute treatment, patients received Carglumic acid tablets for oral suspension at 100 mg/kg/day to 250 mg/kg/day orally administered in 2 to 4 divided doses.

For maintenance treatment, the dosage was reduced over time based on plasma ammonia level and clinical responses. The baseline characteristics of the patient population are shown in Table 5. Table 5: Baseline Characteristics of 23 NAGS Deficiency Patients Treated with Carglumic Acid Tablets for Oral Suspension Patients N=23 Sex Male 14 (61%) Female 9 (39%) Age at initiation of carglumic acid tablets for oral suspension therapy (years) Mean (SD) 2 (4) Min to Max 0 - 13 Age groups at initiation of carglumic acid tablets for oral suspension therapy <30 days 9 (39%) >30 days - 11 months 9 (39%) ≥1 - 13 years 5 (22%) NAGS gene mutations by DNA testing Homozygous 14 (61%) Heterozygous 4 (17%) Not available 5 (22%) Patients current treatment status On-going 18 (78%) Discontinued 5 (22%) The clinical and biochemical data in the 23-patient case series were retrospectively collected, unblinded, and uncontrolled and preclude formal statistical testing.

Short-term efficacy was evaluated using mean and median change in plasma ammonia levels from baseline to days 1 to 3. Persistence of the effect was evaluated using long-term mean and median change in plasma ammonia level. Of the 23 NAGS deficiency patients in the case series, 13 patients had documented plasma ammonia levels prior to carglumic acid tablets for oral suspension treatment and after long-term treatment with carglumic acid tablets for oral suspension and were evaluable.

Table 6 summarizes the plasma ammonia levels at baseline, days 1 to 3 post- carglumic acid tablets for oral suspension treatment, and long-term carglumic acid tablets for oral suspension treatment (mean 8 years) in the 13 evaluable patients. All 13 patients had increased plasma ammonia levels at baseline (mean 271 micromol/L; normal range: 5 to 50 micromol/L). By day 3 and with long-term treatment, normal plasma ammonia levels were attained (Table 6).

Table 6: Plasma Ammonia Levels in NAGS Deficiency Patients at Baseline and After Treatment with Carglumic Acid Tablets for Oral Suspension Time point Patients (N = 13) Ammonia level (micromol/L) Baseline (prior to first dose of carglumic acid tablets for oral suspension) N 13 Mean (SD) 271 (359) Median 157 Range 72-1428 Missing Data 0 Day 1 N 10 Mean (SD) 181 (358) Median 65 Range 25-1190 Missing Data 3 Day 2 N 8 Mean (SD) 69 (78) Median 44 Range 11-255 Missing Data 5 Day 3 N 5 Mean (SD) 27 (11) Median 25 Range 12-42 Missing Data 8 Long-term treatment (mean duration 8 years; median duration 6 years; range 1-16 years based on last available value while on carglumic acid tablets for suspension treatment.) N 13 Mean (SD) 23 (7) Median 24 Range 9-34 Missing Data 0 The mean plasma ammonia level at baseline and the decline that is observed after treatment with carglumic acid tablets for oral suspension in 13 evaluable patients with NAGS deficiency is illustrated in Figure 1.

Figure 1: Mean Plasma Ammonia in 13 Evaluable NAGS Deficiency Patients at Baseline and After Treatment with carglumic acid tablets for oral suspension Image

🧪 Nonclinical Toxicology 138 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of carglumic acid was assessed in a 2-year carcinogenicity study in rats. Carglumic acid was not tumorigenic at oral doses up to 1000 mg/kg/day (approximately 34 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC). Carglumic acid was negative in the Ames test, chromosomal aberration assay in human lymphocytes, and the in vivo micronucleus assay in rats.

There were no effects on fertility or reproductive performance in female rats at oral doses up to 2000 mg/kg/day (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC). In a separate study, mating and fertility were unaffected in male rats at oral doses up to 1000 mg/kg/day (approximately 34 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 135 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of carglumic acid was assessed in a 2-year carcinogenicity study in rats. Carglumic acid was not tumorigenic at oral doses up to 1000 mg/kg/day (approximately 34 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC). Carglumic acid was negative in the Ames test, chromosomal aberration assay in human lymphocytes, and the in vivo micronucleus assay in rats.

There were no effects on fertility or reproductive performance in female rats at oral doses up to 2000 mg/kg/day (approximately 38 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC). In a separate study, mating and fertility were unaffected in male rats at oral doses up to 1000 mg/kg/day (approximately 34 times the maximum reported human maintenance dose [100 mg/kg/day] based on AUC).

📄 Package Label / Principal Display Panel 168 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Bottle label - 5 Tablets in Bottle NDC 68475-006-01 Carglumic Acid Tablets for Oral Suspension 200 mg Store at 20° to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. 5 Tablets Rx only Navinta LLC Carton label - 5 Tablets in Bottle NDC 68475-006-01 Carglumic Acid Tablets for Oral Suspension 200 mg Disperse Carglumic Acid Tablets in water. Do not swallow whole or crushed.

5 Tablets Rx only Navinta LLC Bottle label - 60 Tablets in Bottle NDC 68475-006-02 Carglumic Acid Tablets for Oral Suspension 200 mg Store at 20° to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature]. 60 Tablets Rx only Navinta LLC Carton label - 60 Tablets in Bottle NDC 68475-006-02 Carglumic Acid Tablets for Oral Suspension 200 mg Disperse Carglumic Acid Tablets in water. Do not swallow whole or crushed.

60 Tablets Rx only Navinta LLC 1 2 3 4

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Carglumic Acid — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Carglumic Acid. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.38M
Claims incl. refills
11
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$125,488.19
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Carglumic Acid — the ingredient across all brands.

Top reported reactions

Vomiting147
Ammonia Increased92
Hyperammonaemia56
Hospitalisation51
Death48
Diarrhoea47
Pyrexia31

Reporter sex

745 reports
Male · 48%
Female · 52%

Serious outcomes

Death151
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 103 30
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Navinta LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 5 tablets (68475-0006-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Navinta LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 68475-0003-04 · Navinta 68475-0007-01 · Navinta →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.